Comparison of Two Dosing Regimens of Intravenous Ketorolac for Post-Cesarean Pain Control: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- numeric rating scale at rest
研究概览
简要总结
we aim to compare the analgesic efficacy of two intravenous ketorolac dosing regimens as part of a multimodal analgesic protocol that includes local wound infiltration for postoperative pain management after elective cesarean delivery.
详细描述
Spinal anesthesia will be achieved by injecting 10 mg hyperbaric bupivacaine 0.5% plus 25 mcg fentanyl Prophylactic vasopressor will be administered in all patients, Following delivery, all patients will receive a single dose of dexamethasone (8 mg) along with the first dose of intravenous ketorolac. Subsequent ketorolac doses will be administered every 8 hours.
After closing the fascia, the subcutaneous layer will be infiltrated with 30 mL of 0.25% bupivacaine.
Postoperatively, if the Numeric rating scale is > 3, intravenous nalbuphine 0.1 mg/kg titrated to response, with maximum single dose of 20 mg and maximum daily dose of 160 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •full-term, singleton, pregnant women,
- •aged 18-35 years,
- •scheduled for elective cesarean delivery under spinal anesthesia
排除标准
- •American Society of Anesthesiologists (ASA) physical class III or more
- •multiple gestation. Patients with a history of allergy to any of the study drugs,
- •renal impairment,
- •gastrointestinal bleeding or ulceration
- •inflammatory bowel disease,
- •chronic pain or regular opioid use.
- •Inability to comprehend the numeric pain scale (NRS) or the ObsQoR-11 score
- •requirement for conversion to general anesthesia after spinal anesthesia
研究组 & 干预措施
ketorolac 30
patients will receive intravenous ketorolac at 30 mg/8 h postoperatively
干预措施: Ketorolac 30 mg (Drug)
ketorolac 15 mg
patients will receive intravenous ketorolac at 15 mg/8 h postoperatively
干预措施: Ketorolac 15mg (Drug)
结局指标
主要结局
numeric rating scale at rest
时间窗: 6 hours postoperatively
the patient rates their pain on a scale of 0 to 10, with 0 being "no pain" and 10 being the "worst pain imaginable"
次要结局
- numeric rating scale at rest(at 30 minutes, 12-, 18-, and 24 hours postoperatively)
- total nalbuphine consumption(from 0.5 hour postoperatively to 24 hour postoperatively)
- time to first analgesic requirement(time from immediately postoperatively to time of first analgesic requirement during the first 24 hours)
- numeric rating scale during movement(at 30 minutes, 6-, 12-, 18-, and 24 hours postoperatively)
- ObsQoR-11 score(24 hour postoperatively)
- patient's satisfaction(24 hour postoperatively)